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Comparison of Single-Layer and Triple-Layer TPU MaxFlex Aligners After Intraoral Use
Sponsor: Ayub Medical College, Abbottabad
Summary
This study aims to compare two types of clear orthodontic aligner materials used in dental treatment: single-layer and triple-layer thermoplastic polyurethane (TPU) aligners (MaxFlex). Clear aligners are commonly used to straighten teeth and are preferred for their comfort and aesthetic appearance. Participants will be provided with aligners and instructed to wear them for approximately 22 hours per day for 10 days. The aligners will be collected before use and after the 10-day period. The study will evaluate how the oral environment affects the properties of these materials over time. Laboratory tests will be conducted to measure mechanical properties such as strength, flexibility, and deformation, as well as to examine surface changes under a microscope. The results of this study may help improve the performance and durability of aligners and contribute to better orthodontic treatment outcomes.
Official title: Effects of Intraoral Aging on Mechanical Properties and Surface Morphology of Single-Layer Versus Triple-Layer Thermoplastic Polyurethane (TPU) MaxFlex Aligner Sheets: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 30 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2025-09-13
Completion Date
2026-03-16
Last Updated
2026-05-05
Healthy Volunteers
No
Interventions
Single-Layer Thermoplastic Polyurethane Aligner
Single-layer thermoplastic polyurethane (TPU) clear aligners fabricated from a homogeneous TPU sheet using thermoforming techniques. These aligners are designed to deliver orthodontic forces for tooth movement. Participants will be instructed to wear the aligners intraorally for 10 days for a minimum of 22 hours per day. The aligners will be evaluated before use and after intraoral exposure to assess changes in mechanical properties and surface morphology.
Triple-Layer Thermoplastic Polyurethane Aligner
Triple-layer thermoplastic polyurethane (TPU) clear aligners composed of a multilayer structure including a soft inner layer, a rigid intermediate layer, and a flexible outer layer. These aligners are fabricated using thermoforming techniques and are designed to provide improved force delivery and adaptability. Participants will wear the aligners intraorally for 10 days for at least 22 hours per day. Pre- and post-use evaluations will be conducted to assess mechanical properties and surface morphology changes.
Locations (1)
Akhtar Saeed Medical & Dental College
Lahore, Punjab Province, Pakistan